Endometriosis, OvarianESMRIDNGNCT07446608
MRI-Based Prediction of Dienogest Response in Endometriosis
An observational study of Endometriosis, Ovarian, run by Chungnam National University Sejong Hospital at 1 site in South Korea.
Trial summary
The goal of this prospective observational study is to learn whether magnetic resonance imaging (MRI) findings can help predict treatment response to dienogest in women with endometriosis. Endometriosis is a common gynecologic condition that can cause chronic pelvic pain and negatively affect quality of life. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Endometriosis, Ovarian
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Oct 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will include women aged 19 to 45 years who have been clinically diagnosed with endometriosis by an obstetrician-gynecologist. Eligible participants are those who have not received hormonal treatment within the previous 3 months and have never been treated with dienogest. All participants must provide written informed consent prior to enrollment. Patients with contraindications to dienogest, inability to undergo MRI, current or planned pregnancy within 6 months, or poor general medical condition will be excluded.
Who may be able to join
- Female participants who have received a full explanation of the study and have provided written informed consent
- Women aged 19 to 45 years who have been diagnosed with endometriosis by a board-certified obstetrician-gynecologist
- Patients who have not received any hormonal treatment within the previous 3 months
- Patients who have never been treated with dienogest
Who cannot join
- Patients with a history of treatment with dienogest
- Patients with contraindications to dienogest
- Patients who are unable to undergo magnetic resonance imaging (MRI) (e.g., presence of metallic implants)
- Patients who are currently pregnant or planning pregnancy within the next 6 months
- Patients with poor general medical condition, as judged by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Sejong Chungnam National University Hospital
Sejong, Sejong Special Self-Governing City, 30099
Sukhwan Hyun, MD, PhD, +82-44-995-4724, neo1714@cnuh.co.kr
About this study
Official title: Predicting the Efficacy of Dienogest in Patients With Endometriosis Using MRI
The goal of this prospective observational study is to learn whether magnetic resonance imaging (MRI) findings can help predict treatment response to dienogest in women with endometriosis. Endometriosis is a common gynecologic condition that can cause chronic pelvic pain and negatively affect quality of life. Although dienogest is widely used as a standard medical treatment, individual responses to treatment vary.
The main questions this study aims to answer are:
Read more
- Whether baseline MRI characteristics of endometriotic lesions are associated with improvement in pelvic pain after dienogest treatment.
- Whether MRI findings can help identify patients who are more likely to benefit from dienogest therapy.
Participants diagnosed with endometriosis who are prescribed dienogest as part of their routine clinical care will be enrolled. This study does not assign any investigational intervention. Participants will undergo standard clinical follow-up, including pelvic pain assessment using visual analog scale (VAS) scores, quality of life questionnaires, and routine MRI examinations. Clinical and imaging data will be collected prospectively and analyzed to explore imaging predictors of treatment response.
- Conditions
- Endometriosis, Ovarian
- Keywords
- dienogest, MRI, Observational study
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pelvic pain severity assessed by visual analog scale.
Pelvic pain severity will be measured using the Visual Analog Scale , ranging from 0 to 10, where higher scores indicate more severe pelvic pain.
The primary outcome is the change in Visual Analog Scale score from baseline to 12 months after initiation of dienogest treatment.
Measured: Baseline to 12 months after initiation of dienogest treatment
Secondary outcomes (2)
Change in quality of life assessed by the Endometriosis Health Profile-30 (EHP-30)
Quality of life will be assessed using the Endometriosis Health Profile-30 (EHP-30), a validated patient-reported outcome questionnaire specific to endometriosis.
The Endometriosis Health Profile(EHP-30) core questionnaire scores range from 0 to 100, with higher scores indicating worse health-related quality of life.
The secondary outcome measure is the change in Endometriosis Health Profile(EHP-30) total score from baseline to follow-up during dienogest treatment.
Measured: Baseline to 12 months
Change From Baseline in MRI Characteristics of Endometriotic Lesions
The secondary outcome is the change from baseline in the size of endometriotic lesions measured on magnetic resonance imaging (MRI). Lesion size will be defined as the maximum diameter of the target lesion measured in millimeters on MRI at baseline and after 12 months of dienogest treatment. A reduction in lesion size indicates improvement.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start14 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis, OvarianStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Sejong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukhwan Hyun, Chungnam National University Sejong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446608
- Sponsor's protocol ID
- 2025-05-014
- Acronym
- ESMRIDNG
- Status last verified
- Jan 2026
- First submitted
- 19 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Efficacy of Dienogest in Patients With Endometriosis Using MRI
- ClinicalTrials.gov ID
- NCT07446608
- Acronym / sponsor ID
- ESMRIDNG / 2025-05-014
- Conditions
- Endometriosis, Ovarian
- Keywords
- dienogest, MRI, Observational study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chungnam National University Sejong HospitalUniversity, hospital or other
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective observational study is to learn whether magnetic resonance imaging (MRI) findings can help predict treatment response to dienogest in women with endometriosis. Endometriosis is a common gynecologic condition that can cause chronic pelvic pain and negatively affect quality of life. Although dienogest is widely used as a standard medical treatment, individual responses to treatment vary.
The main questions this study aims to answer are:
- Whether baseline MRI characteristics of endometriotic lesions are associated with improvement in pelvic pain after dienogest treatment.
- Whether MRI findings can help identify patients who are more likely to benefit from dienogest therapy.
Participants diagnosed with endometriosis who are prescribed dienogest as part of their routine clinical care will be enrolled. This study does not assign any investigational intervention. Participants will undergo standard clinical follow-up, including pelvic pain assessment using visual analog scale (VAS) scores, quality of life questionnaires, and routine MRI examinations. Clinical and imaging data will be collected prospectively and analyzed to explore imaging predictors of treatment response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will include women aged 19 to 45 years who have been clinically diagnosed with endometriosis by an obstetrician-gynecologist. Eligible participants are those who have not received hormonal treatment within the previous 3 months and have never been treated with dienogest. All participants must provide written informed consent prior to enrollment. Patients with contraindications to dienogest, inability to undergo MRI, current or planned pregnancy within 6 months, or poor general medical condition will be excluded.
Key inclusion criteria (4 listed)
- Female participants who have received a full explanation of the study and have provided written informed consent
- Women aged 19 to 45 years who have been diagnosed with endometriosis by a board-certified obstetrician-gynecologist
- Patients who have not received any hormonal treatment within the previous 3 months
- Patients who have never been treated with dienogest
Key exclusion criteria (5 listed)
- Patients with a history of treatment with dienogest
- Patients with contraindications to dienogest
- Patients who are unable to undergo magnetic resonance imaging (MRI) (e.g., presence of metallic implants)
- Patients who are currently pregnant or planning pregnancy within the next 6 months
- Patients with poor general medical condition, as judged by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in pelvic pain severity assessed by visual analog scale.
Time frame: Baseline to 12 months after initiation of dienogest treatment
Pelvic pain severity will be measured using the Visual Analog Scale , ranging from 0 to 10, where higher scores indicate more severe pelvic pain. The primary outcome is the change in Visual Analog Scale score from baseline to 12 months after initiation of dienogest treatment.
2 secondary outcomes
Change in quality of life assessed by the Endometriosis Health Profile-30 (EHP-30)
Time frame: Baseline to 12 months
Change From Baseline in MRI Characteristics of Endometriotic Lesions
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, Ovarian, run by Chungnam National University Sejong Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pelvic pain severity assessed by visual analog scale. (time frame: Baseline to 12 months after initiation of dienogest treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.